Usability Engineer , Design Assurance

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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, Quik Clot, Rüsch, Uro Lift and Weck – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit .

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey.

Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

The Usability Engineer 2 supports the development, commercialization, and lifecycle management of safe, effective, and user-friendly medical devices by independently planning and executing usability engineering and human factors activities within a regulated design control environment. Working as part of the Design Assurance organization and cross-functional product development teams, this role partners with Business Unit stakeholders to deliver usability engineering outputs across new product development and sustaining projects.

• Ability to develop protocols and execute usability engineering activities across new product development and sustaining projects in alignment with FDA human factors guidance, IEC 62366, ISO 14971, internal design control procedures, and applicable quality system requirements.
• Conduct and document use specifications, task analyses, user needs assessments, identification of critical tasks, and use-related risk analyses to inform product design and risk management activities.
• Plan, execute, and document formative and summative usability evaluations, including protocol development, participant definition, data collection, study moderation, analysis, and report generation.
• Analyze usability study data to identify usability issues, residual risks, and opportunities for design improvement; recommend appropriate risk controls involving design, labeling, and training as applicable.
• Collaborate with R&D, Quality, Regulatory Affairs, Clinical/Medical Affairs, Marketing, Manufacturing, and Business Unit stakeholders to align usability objectives with project priorities, design requirements, and timelines.
• Collaboration in the recruitment of qualified clinicians for usability studies and moderate usability testing sessions in collaboration with engineering resources.
• Support investigation of usability-related issues, including root cause analysis and corrective/preventive actions (CAPA) or nonconformance activities, as assigned.
• Ensure compliance with company policies, the Code of Ethics, and procedural standards, maintaining high-quality output throughout all usability engineering activities.

• BS in Engineering, Usability Engineering / Ergonomics, Usability Engineering, Cognitive Psychology, Behavioral Psychology, Industrial Design or equivalent degree or related field with…